Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma, 01276.HK) announced that its wholly owned subsidiary, Shanghai Suncadia Medicine Co., Ltd., has received National Medical Products Administration (NMPA) approval to expand the label of adebrelimab injection to include peri-operative treatment of resectable stage II, IIIA and IIIB non-small cell lung cancer (NSCLC) without EGFR mutations or ALK rearrangements.

Adebrelimab now becomes the first domestically developed PD-L1 inhibitor cleared in China for neoadjuvant plus adjuvant use in NSCLC, marking its second approved indication after its February 2023 authorisation for first-line extensive-stage small cell lung cancer (ES-SCLC).

The latest approval is backed by interim results from the randomised, double-blind Phase Ib/III SHR-1316-III-303 study led by Guangdong Provincial People’s Hospital: • Major pathological response (MPR) reached 53.8%, almost triple the control arm. • Two-year event-free survival (EFS) rate was 74.8%, translating to a 48% reduction in recurrence, progression or death risk. • Surgical resection rate hit 88.8%. No new safety signals were observed.

Lung cancer remains China’s leading cancer type by incidence and mortality, with NSCLC accounting for 80–85% of cases. Conventional peri-operative chemotherapy improves five-year survival by roughly 5%; recent immunotherapy advances are reshaping the standard of care, reflected in updated domestic and global guidelines.

Comparable PD-L1 products—atezolizumab (Tecentriq), avelumab (Bavencio) and durvalumab (Imfinzi)—generated combined global sales of USD 11.05 billion in 2025, highlighting the commercial potential of this drug class. Hengrui Pharma has invested approximately RMB 1.23 billion to date in adebrelimab’s development.

Management cautions that post-approval manufacturing and sales remain subject to market and operational uncertainties.